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NCT01360866 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,944
- Enrollment target
NCT01360866 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 2,944 participants.
The verdict
NCT01360866, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,944 participants
- Enrollment target
Study Summary
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
Interventions
- DRUG Escitalopram
- DRUG Sertraline
- DRUG Fluoxetine
- DRUG OPC-34712
- DRUG Paroxetine CR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,944 participants |
| Start Date | 2011-10 |
| Est. Completion | 2017-05-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01360866
The ClinicalTrials.gov registry entry for NCT01360866 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,944 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Escitalopram is the first listed.
NCT01360866 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01360866 about?
NCT01360866 is a clinical study titled "Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)". To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
What is the current status of trial NCT01360866?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,944 participants. The study started on 2011-10. Estimated completion is 2017-05-18.
What interventions are being tested in trial NCT01360866?
The interventions under investigation include: Escitalopram (DRUG), Sertraline (DRUG), Fluoxetine (DRUG), OPC-34712 (DRUG), Paroxetine CR (DRUG).
Who is sponsoring clinical trial NCT01360866?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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